Headache DisordersNCT04080258
Effectiveness of Osteopathic Manipulative Therapy in Paediatric Patients, With High Frequency Headache.
A study testing Osteopathic manipulative therapy (OMTh) and Light Touch Therapy (LTT) in people with Headache Disorders and Primary Headache Disorder, run by Antonio Francesco Urbino at 1 site in Italy.
Trial summary
The aim of this study is to evaluate the effectiveness of osteopathic manipulative therapy, in supporting prophylactic medications in paediatric patients, with high frequency headache. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Headache Disorders, Primary Headache Disorder
- What is being tested?
- Osteopathic manipulative therapy (OMTh) and Light Touch Therapy (LTT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jun 2018to 18 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of primary high-frequency headache attacks.
- No reduction or inconsistent reduction of attacks after two months of prophylactic treatment.
Who cannot join
- Secondary headache.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Centro Cefalee dell'età evolutiva - Ospedale Infantile Regina Margherita S.C. Pediatria d'Urgenza.
Torino, 10126
Antonio F Urbino, Medical
About this study
The aim of this study is to evaluate the effectiveness of osteopathic manipulative therapy, in supporting prophylactic medications in paediatric patients, with high frequency headache.
Read the detailed description
Headache is one of the most common medical complaints in childhood, with migraine and tension-type headaches (TTHs) being the most frequent diseases. The prevalence of tension-type headache (TTH) varies from 10% to 25% in school children and adolescents. Therefore a range varying from 0,1% to 5,9% of this population presents chronic tension-type headache, occuring at least 15 days on a monthly basis.
The tension-type headache is most likely multifactorial. In children, a connection seems possible between tension-type headache and psychosocial stress, psychiatric disorders, muscular stress, or oromandibular dysfunction.
The treatment of tension-type headache covers a systemic approach that includes both pharmacologic and nonpharmacologic therapies, such as biobehavioural management, and patient and family education regarding lifestyle modifications to develop and/or maintain healthy habits. Efficacy of these therapies is still unclear. Complementary therapies could be a good support to pharmacologic treatment. Osteopathic treatment results effective in some paediatric conditions, but in primary headache the possible efficacy is still unknown.
- Conditions
- Headache Disorders, Primary Headache Disorder
- Being tested
- Osteopathic manipulative therapy (OMTh), Light Touch Therapy (LTT)
- Keywords
- Headache Disorders, Primary Headache
- Medical subject headings
- Headache Disorders, Headache Disorders, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulative therapy (OMTh)Other
The Osteopathic Manipulative Therapy includes both evaluation and treatment. The evaluation is semi-structured, two osteopaths will assess the presence of somatic dysfunctions which have to include the hyoid-pharyngeal, laryngeal, temporo-mandibular and lingual areas.
The therapy is based on the treatment of somatic dysfunctions with different approaches that include: the balanced ligamentous tension technique, the myofascial release, the visceral manipulation, and the balanced membranous tension technique. The OMTh lasts for 45 minutes of which 15 of evaluation and 30 of treatment.
Light Touch Therapy (LTT)Other
The Light Touch Therapy is a sham treatment consistent with the OMTh one during the phase of evaluation. The treatment retains the same areas used for osteopathic approach but avoids prolonged touch in any area of the body by moving the hands every few seconds and by flattening and softening the surface of the hands in order to minimize focal areas of force.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulative Therapy | Experimental | Osteopathic Manipulative Therapy (OMTh). Patients in the OMTh group will receive 5 Osteopathic manipulative therapies: the first at baseline, the second after 1 week, the third after 3 weeks, and then 2 more treatments on a monthly basis. The protocol will last for three months. Receives: Other: Osteopathic manipulative therapy (OMTh) |
| Light Touch Therapy | Sham comparator | Participants to the LTT group will receive the protocol at the same date of the OMTh group. Receives: Other: Light Touch Therapy (LTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days with headache
Difference in number of days per month with headache
Measured: At baseline (T0), after 1 month (T1), at 3 months from baseline (T2) and follow-up at 6 months from baseline.
Secondary outcomes (4)
Reduction of analgesic use
Difference in reduction of analgesic use per month
Measured: At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline
Reduction of functional disability (school and leisure activity)
Days per month with functional disability.
Measured: At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline
Reduction of headache intensity
Difference in intensity of pain: mild, moderate and severe
Measured: At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline
Adverse event
Symptoms such as increased of pain that could occur after the Osteopathic Manipulative Therapy or Light Touch Therapy
Measured: From first treatment (1 week post-baseline) up to end of treatment course (3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start18 Jun 2018
- Primary completion18 Jun 2020 (estimated)
- Study completion18 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Headache DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two arms randomized controlled trial. The experimental group will receive Osteopathic Manipulative Therapy and the Active Comparator will receive Light Touch Therapy.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antonio Francesco Urbino
- Sponsor type
- University, hospital or other
- Collaborators
- Scuola Superiore di Osteopatia Italiana
- Responsible party
- Sponsor-investigator, Antonio Francesco Urbino, A.O.U. Città della Salute e della Scienza
- Investigators
- Antonio F Urbino, Medical, Principal investigator, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080258
- Sponsor's protocol ID
- 0063257
- Status last verified
- Sep 2019
- First submitted
- 4 Sep 2019
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huguet A, Tougas ME, Hayden J, McGrath PJ, Chambers CT, Stinson JN, Wozney L. Systematic Review of Childhood and Adolescent Risk and Prognostic Factors for Recurrent Headaches. J Pain. 2016 Aug;17(8):855-873.e8. doi: 10.1016/j.jpain.2016.03.010. Epub 2016 Apr 19.
PubMed 27102894Gofshteyn JS, Stephenson DJ. Diagnosis and Management of Childhood Headache. Curr Probl Pediatr Adolesc Health Care. 2016 Feb;46(2):36-51. doi: 10.1016/j.cppeds.2015.11.003. Epub 2015 Dec 29.
PubMed 26750538Kroon Van Diest AM, Powers SW. Cognitive Behavioral Therapy for Pediatric Headache and Migraine: Why to Prescribe and What New Research Is Critical for Advancing Integrated Biobehavioral Care. Headache. 2019 Feb;59(2):289-297. doi: 10.1111/head.13438. Epub 2018 Nov 16.
PubMed 30444269Posadzki P, Lee MS, Ernst E. Osteopathic manipulative treatment for pediatric conditions: a systematic review. Pediatrics. 2013 Jul;132(1):140-52. doi: 10.1542/peds.2012-3959. Epub 2013 Jun 17.
PubMed 23776117Cerritelli F, Ginevri L, Messi G, Caprari E, Di Vincenzo M, Renzetti C, Cozzolino V, Barlafante G, Foschi N, Provinciali L. Clinical effectiveness of osteopathic treatment in chronic migraine: 3-Armed randomized controlled trial. Complement Ther Med. 2015 Apr;23(2):149-56. doi: 10.1016/j.ctim.2015.01.011. Epub 2015 Jan 21.
PubMed 25847552
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Osteopathic Manipulative Therapy in Paediatric Patients, With High Frequency Headache.
- ClinicalTrials.gov ID
- NCT04080258
- Acronym / sponsor ID
- 0063257
- Conditions
- Headache Disorders, Primary Headache Disorder
- Keywords
- Headache Disorders, Primary Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Antonio Francesco UrbinoUniversity, hospital or other
- Collaborators
- Scuola Superiore di Osteopatia Italiana
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 18 Jun 2020 (estimated)
- Study completion
- 18 Dec 2020 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effectiveness of osteopathic manipulative therapy, in supporting prophylactic medications in paediatric patients, with high frequency headache.
Detailed description
Headache is one of the most common medical complaints in childhood, with migraine and tension-type headaches (TTHs) being the most frequent diseases. The prevalence of tension-type headache (TTH) varies from 10% to 25% in school children and adolescents. Therefore a range varying from 0,1% to 5,9% of this population presents chronic tension-type headache, occuring at least 15 days on a monthly basis.
The tension-type headache is most likely multifactorial. In children, a connection seems possible between tension-type headache and psychosocial stress, psychiatric disorders, muscular stress, or oromandibular dysfunction.
The treatment of tension-type headache covers a systemic approach that includes both pharmacologic and nonpharmacologic therapies, such as biobehavioural management, and patient and family education regarding lifestyle modifications to develop and/or maintain healthy habits. Efficacy of these therapies is still unclear. Complementary therapies could be a good support to pharmacologic treatment. Osteopathic treatment results effective in some paediatric conditions, but in primary headache the possible efficacy is still unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A two arms randomized controlled trial. The experimental group will receive Osteopathic Manipulative Therapy and the Active Comparator will receive Light Touch Therapy.
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulative Therapy | Experimental | Other: Osteopathic manipulative therapy (OMTh)Osteopathic Manipulative Therapy (OMTh). Patients in the OMTh group will receive 5 Osteopathic manipulative therapies: the first at baseline, the second after 1 week, the third after 3 weeks, and then 2 more treatments on a monthly basis. The protocol will last for three months. |
| Light Touch Therapy | Sham comparator | Other: Light Touch Therapy (LTT)Participants to the LTT group will receive the protocol at the same date of the OMTh group. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosis of primary high-frequency headache attacks.
- No reduction or inconsistent reduction of attacks after two months of prophylactic treatment.
Key exclusion criteria (1 listed)
- Secondary headache.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic manipulative therapy (OMTh)The Osteopathic Manipulative Therapy includes both evaluation and treatment. The evaluation is semi-structured, two osteopaths will assess the presence of somatic dysfunctions which have to include the hyoid-pharyngeal, laryngeal, temporo-mandibular and lingual areas. The therapy is based on the treatment of somatic dysfunctions with different approaches that include: the balanced ligamentous tension technique, the myofascial release, the visceral manipulation, and the balanced membranous tension technique. The OMTh lasts for 45 minutes of which 15 of evaluation and 30 of treatment. | Other | Osteopathic Manipulative Therapy |
| Light Touch Therapy (LTT)The Light Touch Therapy is a sham treatment consistent with the OMTh one during the phase of evaluation. The treatment retains the same areas used for osteopathic approach but avoids prolonged touch in any area of the body by moving the hands every few seconds and by flattening and softening the surface of the hands in order to minimize focal areas of force. | Other | Light Touch Therapy |
Primary outcome
Number of days with headache
Time frame: At baseline (T0), after 1 month (T1), at 3 months from baseline (T2) and follow-up at 6 months from baseline.
Difference in number of days per month with headache
4 secondary outcomes
Reduction of analgesic use
Time frame: At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline
Reduction of functional disability (school and leisure activity)
Time frame: At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline
Reduction of headache intensity
Time frame: At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline
Adverse event
Time frame: From first treatment (1 week post-baseline) up to end of treatment course (3 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Background: PubMed 27102894Huguet A, Tougas ME, Hayden J, McGrath PJ, Chambers CT, Stinson JN, Wozney L. Systematic Review of Childhood and Adolescent Risk and Prognostic Factors for Recurrent Headaches. J Pain. 2016 Aug;17(8):855-873.e8. doi: 10.1016/j.jpain.2016.03.010. Epub 2016 Apr 19.
- Background: PubMed 26750538Gofshteyn JS, Stephenson DJ. Diagnosis and Management of Childhood Headache. Curr Probl Pediatr Adolesc Health Care. 2016 Feb;46(2):36-51. doi: 10.1016/j.cppeds.2015.11.003. Epub 2015 Dec 29.
- Background: PubMed 30444269Kroon Van Diest AM, Powers SW. Cognitive Behavioral Therapy for Pediatric Headache and Migraine: Why to Prescribe and What New Research Is Critical for Advancing Integrated Biobehavioral Care. Headache. 2019 Feb;59(2):289-297. doi: 10.1111/head.13438. Epub 2018 Nov 16.
- Background: PubMed 23776117Posadzki P, Lee MS, Ernst E. Osteopathic manipulative treatment for pediatric conditions: a systematic review. Pediatrics. 2013 Jul;132(1):140-52. doi: 10.1542/peds.2012-3959. Epub 2013 Jun 17.
- Background: PubMed 25847552Cerritelli F, Ginevri L, Messi G, Caprari E, Di Vincenzo M, Renzetti C, Cozzolino V, Barlafante G, Foschi N, Provinciali L. Clinical effectiveness of osteopathic treatment in chronic migraine: 3-Armed randomized controlled trial. Complement Ther Med. 2015 Apr;23(2):149-56. doi: 10.1016/j.ctim.2015.01.011. Epub 2015 Jan 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio F Urbino, Medical principal investigator
A.O.U. Città della Salute e della Scienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic manipulative therapy (OMTh) and Light Touch Therapy (LTT) in people with Headache Disorders and Primary Headache Disorder, run by Antonio Francesco Urbino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donatella F Bagagiolo, Osteopath (0039 3405587818, donatella.bagagiolo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days with headache (time frame: At baseline (T0), after 1 month (T1), at 3 months from baseline (T2) and follow-up at 6 months from baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04080258, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.